The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Summary

In the VITdAL-ICU trial using a large oral dose of vitamin D3 in 480 adult critically ill patients, there was no benefit regarding the primary endpoint hospital length of stay. However, the predefined subgroup with severe vitamin D deficiency (25(OH)D ≤ 12ng/ml) had significantly lower 28-day mortality (36.3% placebo vs. 20.4% vitamin D group, hazard ratio (HR) 0.52 (0.30-0.89), number needed to treat = 6). Therefore, high-dose vitamin D3 in a population of severely vitamin D deficient critically ill patients is a promising and inexpensive intervention that requires confirmatory multicenter studies.

To date, only 7 interventions (e.g. noninvasive ventilation or prone positioning) have ever demonstrated mortality benefit for Intensive Care Unit (ICU) patients in multicenter trials. In case of benefit, vitamin D treatment in critically ill patients could be immediately implemented worldwide.

Conditions

• Critical Illness
• Vitamin D Deficiency
• Covid19

Interventions

DRUG

Cholecalciferol

oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days

DRUG

Placebo

oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days

Sponsors & Collaborators

• Medical University of Vienna

  collaborator OTHER

• Hospital Barmherzige Brüder St. Veit

  collaborator UNKNOWN

• Klinikum Klagenfurt am Wörthersee

  collaborator OTHER

• Johannes Kepler University of Linz

  collaborator OTHER

• Krankenhaus Barmherzige Schwestern Linz

  collaborator OTHER

• Barmherzige Brüder Vienna

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• The Queen Elizabeth Hospital

  collaborator OTHER

• Goethe University

  collaborator OTHER

• Kages

  collaborator OTHER

• KABEG Management

  collaborator OTHER

• Centre Hospitalier Régional de la Citadelle

  collaborator OTHER

• Centre Hospitalier Universitaire de Charleroi

  collaborator OTHER

• Centre Hospitalier Universitaire Mons

  collaborator UNKNOWN

• Wuerzburg University Hospital

  collaborator OTHER

• Royal Bolton Hospital NHS Foundation Trust

  collaborator OTHER

• Heartlands Hospital

  collaborator UNKNOWN

• Royal Oldham Hospital

  collaborator UNKNOWN

• East Lancashire Hospitals NHS Trust

  collaborator OTHER

• University of Plymouth

  collaborator OTHER

• Royal Victoria Hospital, Belfast

  collaborator OTHER

• Great Western Hospital

  collaborator UNKNOWN

• Mid Yorkshire Teaching NHS Trust

  collaborator OTHER

• Musgrove Park Hospital

  collaborator UNKNOWN

• Scunthorpe General Hospital

  collaborator UNKNOWN

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Nottingham University Hospitals

  collaborator UNKNOWN

• Hospital Barmherzige Brüder Graz

  collaborator UNKNOWN

• University Hospital Kiel

  collaborator UNKNOWN

• University Hospital, Bonn

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• Klinikum rechts der Isar der TUM

  collaborator UNKNOWN

• Landeskrankenhaus Villach

  collaborator UNKNOWN

• Medical University of Graz

  lead OTHER

Principal Investigators

• Karin Amrein, MD, MSc · Medical University of Graz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-10

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• Austria
• Belgium
• Germany
• United Kingdom

Study Locations